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Inactive Poliovirus Vaccine

Phase 3

Poliomyelitis | Vaccine | Infectious Disease |Sanofi|Trials Updated: Mar 29, 2013

Inactive Poliovirus Vaccine development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jul 2011

Inactive Poliovirus Vaccine target and mechanism

ModalityVaccine

Also known as SP059

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment74

FDA Designations

No designations recorded

Inactive Poliovirus Vaccine clinical trials

Inactive Poliovirus Vaccine · 1 trial · 2 indications

Phase 3 1
NCT01389687Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in JapanPoliomyelitis
COMPLETED74 Analytics
PHASE3COMPLETED
Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan
PoliomyelitisUnlock trial analytics

Study Endpoints

Primary Endpoints

A description of the anti-Polio 1, 2 and 3 antibody titers post-vaccination
1 month post-vaccination 3

Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay.

Secondary Endpoints

Immunogenicity (in terms of seroprotection and Geometric Mean Titers) of inactivated polio vaccine (IPV) before and after the primary vaccination and before and after the booster vaccination.
Day 0 and 1 month post-vaccination
Description of the safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with IPV
Day 0 up to 12 months post-vaccination
Immunogenicity (in terms of anti-Polio 1, 2, and 3 titers ≥ 8 [1/dilution], individual antibodies' titers and Geometric Mean Titers) of inactivated polio vaccine (IPV) after the booster vaccination.
1 month post-booster vaccination
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Study GroupEXPERIMENTAL -

Interventions

NameTypeDescription
Inactive Poliovirus VaccineBIOLOGICAL0.5 mL, Subcutaneous
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Eligibility Criteria

Age Range3 Months to 68 Months
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Aged 3 to 68 months inclusive (recommended 3 to 8 months) on the day of inclusion * Informed consent form signed by the parent(s) or other legal representative * Able to attend all scheduled visits and to comply with all trial procedures Exclusion Criteria: * Fever ≥ 37.5°C (a...

Countries:Japan
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Frequently asked questions about Inactive Poliovirus Vaccine

What is Inactive Poliovirus Vaccine used for?

Inactive Poliovirus Vaccine is used for the prevention of poliomyelitis, commonly known as polio. It is a vaccine developed by Sanofi for protection against poliovirus infection. The vaccine is intended for use in infants, with clinical study enrollment beginning at 3 months of age.

Who makes Inactive Poliovirus Vaccine?

Inactive Poliovirus Vaccine is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical development program for this vaccine candidate.

What phase is Inactive Poliovirus Vaccine in?

Inactive Poliovirus Vaccine is in Phase 3 clinical development. The Phase 3 study has been completed. The vaccine is investigational and is not approved for commercial use.

What clinical trials is Inactive Poliovirus Vaccine in?

Inactive Poliovirus Vaccine has been evaluated in one completed Phase 3 trial, NCT01389687, titled "Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan." The trial enrolled 74 infants in Japan and studied a three-dose primary and booster vaccination regimen.

How is Inactive Poliovirus Vaccine administered?

Inactive Poliovirus Vaccine is administered subcutaneously. The Phase 3 trial NCT01389687 evaluated a three-dose primary vaccination series followed by a booster dose in infants in Japan.